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Completed

NCT Number: NCT05940129

Women and Child, Safety, Health, and Empowerment

Gender-based violence (GBV) (including homicide) is one of the leading causes of maternal and child (fetus, newborn or infant) mortality and morbidity in limited resource settings such as India. This study is evaluating the feasibility, acceptability and preliminary efficacy of WC-SHE (Women and Children-Safety, Health and Empowerment) intervention developed to promote health and safety outcomes of mother and children in rural and/or tribal regions in India. The aim will be to refine, optimize and standardize the WC-SHE intervention and its added components, develop fidelity measures, conduct a feasibility and acceptability evaluation of the intervention and implementation procedures as well as examine preliminary efficacy outcomes of WC-SHE.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Over 18 years of age
  • Currently pregnant
  • Experienced intimate partner and/or in-law abuse in the past
  • Residing in rural or tribal areas in India

Exclusion criteria

  • Under 18 years of age
  • Not currently pregnant
  • No experience of intimate partner and/or in law abuse
  • Not residing in rural or tribal areas in India

Treatment and study plan

Women and Child, Safety, Health and Empowerment (WC-SHE)

Behavioral

The WC-SHE component includes a risk assessment and tailored safety planning for women in domestic violence relationships. In addition, the component involves one-on-one education with husbands and in-laws. The economic empowerment component is designed to support women and their husbands in economic empowerment activities. The advocacy arm involves community education of husbands and in-laws, advocacy support by a support committee comprised of multidisciplinary professionals and phone support by women community resource persons

Primary outcomes

  1. Severity and frequency of abuse by husband and in-laws as measured by the adapted Conflict Tactics Scale (CTS2)

    Time frame: Baseline, 3 months, 6 months

    Severity and frequency of abuse is assessed by the adapted version of the Revised Conflict Tactics Scale . Response categories range from 0 (never) to very 7 (frequently). Higher overall scores mean more conflict. Measured at Baseline, 3 months, 6 months.

  2. Number of maternal safety behaviors as assessed by the Safety Behavior Checklist

    Time frame: Baseline, 3 months, 6 months

    The Safety Behavior Checklist is used to measure the number of safety strategies and support services used. Measured at Baseline, 3 months, 6 months.

  3. Victim empowerment related to safety as assessed by the Measure of Victim Empowerment Related to Safety (MOVERS) Scale

    Time frame: Baseline, 3 months, 6 months

    The MOVERS scale is a 13 item scale that measures survivor empowerment within the domain of safety. Participants respond to each item using a five-point Likert scale (from "never true" to "always true. Possible score range 13-65. Higher scores indicate higher levels of empowerment related to safety. Measured at Baseline, 3 months, 6 months.

  4. Uncertainty in choosing safety options as assessed by the Adapted Decisional Conflict scale

    Time frame: Baseline, 3 months, 6 months

    The Adapted decisional conflict scale is used to measure decisional conflict for safety. The response options ranged from strongly disagree to strongly agree, with higher scores indicating lower decisional conflict. Decisional Conflict Scale scores range from 0(no decisional conflict) to 100 (high decisional conflict). Measured at Baseline, 3 months, 6 months.

  5. Depression as assessed by the Patient Health Questionnaire

    Time frame: Baseline, 3 months, 6 months

    The Patient Health Questionnaire (PHQ-9) is used to measure depression; Total scores of 5, 10, 15, and 20 represent cut points for mild, moderate, moderately severe and severe depression. Score range 0-27. Measured at Baseline, 3 months, 6 months.

  6. Probable Post Traumatic Stress Disorder (PTSD) in primary care settings

    Time frame: Baseline, 3 months, 6 months

    Primary Care PTSD Screen is a 5 item screen used to identify participants with probable PTSD in primary care settings. The items are rated on a binary scale (No, Yes). Score range 1-5. Higher scores indicate increased post traumatic stress symptoms. Measured at Baseline, 3 months, 6 months.

  7. Physical health status

    Time frame: Baseline, 3 months, 6 months

    For self-rated physical health, participants are asked about how would they describe their health during pregnancy (or post-delivery). The response options include poor, fair and excellent with poor coded as 1, fair as 2 and excellent as 3. Measured at Baseline, 3 months, 6 months.

  8. Fetal safety as measured by occurrence of fetal loss

    Time frame: Post intervention up to 6 months

    Fetal loss includes post-intervention occurrence of any induced abortion or miscarriage, spontaneous abortion or miscarriage, or occurrence of fetal mortality or still birth

  9. Newborn/infant safety as measured by self-reported items developed by the study team

    Time frame: 6 months

    The following items are used to measure newborn or infant safety, (a) participants are asked about concern for the child's mistreatment by the participants husband or in-laws. The response options range from never (0) to always (4). (b) Participants are asked if there is concern about harm to the child by anyone, with yes/no response options; Any incident of death of a child within few weeks post-delivery is based on participants' self-reports

  10. Newborn/infant health as measured by two items developed by the study team

    Time frame: 6 months

    Newborn/infant health is measured by number of participants who delivered a low birth weight or pre-term child. Participants are asked if newborn was (a) a low birthweight child; and (b) child born preterm.

  11. Level of satisfaction with child's health and health-related issues as assessed by the Postpartum Quality of Life (PQOL) measure

    Time frame: 6 months

    Participants are asked adapted items from the child care dimension of the Postpartum Quality of Life (PQOL) measure. The response options for items range from very dissatisfied to very satisfied and frequency levels ranging from never to always. Score range 16-80, with higher scores showing better quality of life.

Secondary outcomes

  1. Self-efficacy for safety as assessed by an item developed by study team

    Time frame: Baseline, 3 months, 6 months

    Self-efficacy for safety is measured using one item that assesses for the level of confidence women have in their ability to implement measures to keep themselves safe from experiencing abuse and mistreatment. The response options range from not confident at all to very confident. Measured at Baseline, 3 months, 6 months.

  2. Resilience as assessed by the Connor Davidson Resilience Scale

    Time frame: Baseline, 3 and 6 months

    Resilience is measured using the 10-item Connor-Davidson Resilience Scale; Respondents rate items on a 5-point Likert scale, ranging from 0 (not true at all) to 4 (true nearly all the time). Each item has a minimum score of 0 and a maximum score of 4.

  3. Sources of support as assessed by the Brief Perceived Social Support Questionnaire

    Time frame: Baseline, 3 months, 6 months

    Perceived sources of support are measured using the Brief Perceived Social Support. The questionnaire.measures general perceived social support with a 6 item, five-point Likert scale ranging from 1 (not true at all) to 5 (very true). Higher scores indicate higher levels of perceived social support. Possible score 6-30. Measured at Baseline, 3 months, 6 months.

  4. Number of Self- care behaviors as measured by the items developed by the study team

    Time frame: Baseline, 3 months, 6 months

    Women are asked about the number of care visits and visits to healthcare providers for specific health concerns. Change in self care behaviors will be assessed by change in attending the minimum number of recommended care visits; and number of visits to medical providers for health concerns. Measured at Baseline, 3 months, 6 months.

  5. Economic stress

    Time frame: Baseline, 3 months, 6 months

    Participants are asked about how often they ran out of money for necessities (e.g., food, housing etc for themselves or/and their children). The response options include never, once or twice, every month or monthly, every week or weekly, every day or daily. Measured at Baseline, 3 months, 6 months.

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Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Official study title

Integrating Maternal, Fetal, Newborn or Infant Safety in Antenatal and Post-natal Care Services for Rural and Tribal Women in India

Acronym: WC-SHE

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 11, 2023
Registry last updated
Dec 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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